UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 4, 2022, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended June 30, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filling.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 104 |
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Press Release issued by Dyne Therapeutics, Inc. on August 4, 2022 Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DYNE THERAPEUTICS, INC. |
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Date: August 4, 2022 |
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By: |
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/s/ Joshua Brumm |
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Name: |
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Joshua Brumm |
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Title: |
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President and Chief Executive Officer |
Exhibit 99.1
Dyne Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights
- Initiation of Patient Dosing in Multiple Ascending Dose Clinical Trials for DYNE-251 in DMD and DYNE-101 in DM1 On Track for Mid-2022 -
WALTHAM, Mass., August 4, 2022 – Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the second quarter of 2022 and business highlights.
“We are executing on our global development strategy, including achieving our first regulatory clearances for our DYNE-251 and DYNE-101 clinical trials. We also continue to engage globally with regulators, as well as clinicians and members of the Duchenne and myotonic dystrophy communities as we prepare to begin dosing patients in both trials shortly,” said Joshua Brumm, president and chief executive officer of Dyne. “The second half of the year looks to be very exciting, as we work to bring DYNE-251 and DYNE-101 into the clinic and advance our efforts to help address unmet needs for people living with serious muscle diseases.”
Business Highlights
Second Quarter 2022 Financial Results
Cash position: Cash, cash equivalents and marketable securities were $291.8 million as of June 30, 2022, which is anticipated to fund operations into the second half of 2024.
Research and development (R&D) expenses: R&D expenses were $46.7 million for the quarter ended June 30, 2022, compared to $23.9 million for the quarter ended June 30, 2021.
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General and administrative (G&A) expenses: G&A expenses were $6.1 for the quarter ended June 30, 2022, compared to $6.3 million for the quarter ended June 30, 2021.
Net loss: Net loss for the quarter ended June 30, 2022 was $52.3 million, or $1.01 per basic and diluted share. This compares with a net loss of $30.0 million, or $0.58 per basic and diluted share, for the quarter ended June 30, 2021.
About Dyne Therapeutics
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne has a broad portfolio of programs for serious muscle diseases, including candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Dyne’s strategy, future operations, prospects and plans, objectives of management, the potential of the FORCE platform, the anticipated timelines for dosing patients in the DYNE-251 trial and the DYNE-101 trial, the expectation of regulatory clearances in additional countries and Dyne’s cash runway, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Dyne may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the initiation and completion of preclinical studies and clinical trials; the timing of and Dyne’s ability to initiate and enroll patients in clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; whether Dyne’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements for the period anticipated or at all; uncertainties associated with the impact of the COVID-19 pandemic on Dyne’s business and operations; as well as the risks and uncertainties identified in Dyne’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-Q and in subsequent filings Dyne may make with the SEC. In addition, the forward-looking statements included in this press release represent Dyne’s views as of the date of this press release. Dyne anticipates that subsequent events and developments will cause its views to change. However, while Dyne may
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elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Dyne’s views as of any date subsequent to the date of this press release.
Dyne Therapeutics, Inc. |
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Condensed Consolidated Statement of Operations (Unaudited) |
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(in thousands, except share and per share data) |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
46,664 |
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$ |
23,872 |
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$ |
74,899 |
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$ |
42,496 |
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General and administrative |
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6,091 |
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6,293 |
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13,638 |
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12,802 |
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Total operating expenses |
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52,755 |
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30,165 |
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88,537 |
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55,298 |
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Loss from operations |
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(52,755 |
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(30,165 |
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(88,537 |
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(55,298 |
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Other (expense) income, net |
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451 |
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210 |
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650 |
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375 |
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Net loss |
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$ |
(52,304 |
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$ |
(29,955 |
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$ |
(87,887 |
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$ |
(54,923 |
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Net loss per share—basic and diluted |
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$ |
(1.01 |
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$ |
(0.58 |
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$ |
(1.70 |
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$ |
(1.09 |
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Weighted-average common shares outstanding used in net |
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51,679,536 |
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51,216,254 |
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51,640,706 |
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50,349,193 |
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Dyne Therapeutics, Inc. |
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Condensed Consolidated Balance Sheet Data (Unaudited) |
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(in thousands) |
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June 30, |
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December 31, |
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2022 |
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2021 |
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Assets |
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Cash, cash equivalents and marketable securities |
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$ |
291,838 |
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$ |
376,571 |
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Other assets |
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48,188 |
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49,092 |
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Total assets |
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$ |
340,026 |
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$ |
425,663 |
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Liabilities and Stockholders’ Equity |
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Liabilities |
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52,967 |
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57,466 |
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Stockholders’ equity |
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287,059 |
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368,197 |
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Total liabilities and stockholders’ equity |
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$ |
340,026 |
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$ |
425,663 |
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Contact:
Dyne Therapeutics
Amy Reilly
areilly@dyne-tx.com
857-341-1203
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